BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 3935274 · Received July 15, 2014

    Report

    Report Number
    0001811755-2014-02528
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DISASSEMBLY WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH VISUAL INSPECTION. UPON DISASSEMBLY, IT WAS FOUND THAT THE HOUSING WAS CRACKED AT THE SCREW BOSS, WHICH CAN LEAD TO THE REPORTED EVENT AND CAN BE CAUSED BY A MATERIAL FATIGUE ISSUE OR IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY, THE TRIGGER OF THE DEVICE DISASSEMBLED. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413732 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1